Brain TumorCRPBTNCT02129712
Neuroplasticity-Based Cognitive Remediation for Pediatric Brain Tumor Survivors
A study testing Cognitive training in people with Brain Tumor, run by Vanderbilt University at 1 site in United States.
Trial summary
This research will leverage novel pilot research conducted by the investigators to take important first steps in addressing neurocognitive late effects by intervening early, during treatment, with a promising computerized cognitive remediation program to prevent the downward trajectory of neurocognitive function… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2014to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newly diagnosed brain tumor patients who are between the ages of 7 years and 16 years, 11 months old and their parents
- Patients and their parents must be fluent English speakers
Who cannot join
- Patient's brain tumor diagnosis cannot be a recurrence of a previous cancer
- No previous history of another form of cancer
- Patients who are deemed legally blind will be excluded from participating
Trial locations and contacts
1 site in 1 country.
About this study
This research will leverage novel pilot research conducted by the investigators to take important first steps in addressing neurocognitive late effects by intervening early, during treatment, with a promising computerized cognitive remediation program to prevent the downward trajectory of neurocognitive function experienced by pediatric brain tumor survivors. Specifically, we propose to test the feasibility, acceptability, and initial proof of concept of a neuroplasticity-based adaptive cognitive training program (Cogmed) to train working memory (WM) and attention in newly diagnosed youth with a brain tumor. Further, we will test the feasibility of using this intervention in a true prospective design beginning pre-surgery to examine the effects of this intervention in deflecting the downward trajectory of cognitive function in children with brain tumors during treatment. We will also use functional neuroimaging (near infrared spectroscopy - "NIRS") to examine the effects of this program on brain activation in frontal regions that are affected by treatment. Findings from this pilot study will inform the development of a large multi-site randomized efficacy trial to test an individualized cognitive training program.
Aim 1. To test the feasibility and acceptability of enrolling youth (7 to 16 years-old) with newly diagnosed brain tumors at time of diagnosis, following patients for 10 weeks, delivering the Cogmed computer-based training program in a randomized trial at 10-weeks post-diagnosis, and following patients to 1 year post-diagnosis.
Aim 2. To test the initial acceptability and efficacy of the Cogmed training program on cognitive function in newly diagnosed pediatric brain tumor patients.
Read the detailed description
Over 4,000 children are diagnosed with brain tumors in the U.S. each year and advances in treatment have led to significant increases in survival rates for these patients. However, as a result of the disease and treatment with surgery, radiation, and chemotherapy, pediatric brain tumor patients show deficits in frontal lobe functions including several aspects of executive function, showing significant declines over time. Remediation of these deficits is a critical target for research. Major changes in brain maturation and connectivity occur during childhood and adolescence, making this a potentially critical window of opportunity for neuroplasticity-based cognitive interventions to support the neural changes that integrate multiple key regions. Computerized cognitive training programs have been used successfully with patients with schizophrenia, individuals with ADHD, and prodromal adolescents at risk for psychosis. However, these programs have been limited in their application to pediatric brain tumor survivors and untested in brain tumor patients who are undergoing treatment. We aim to blend longitudinal and intervention research designs used successfully in previous studies to test the feasibility, acceptability, and initial efficacy of a neuroplasticiy-based cognitive training program, Cogmed, to enhance working memory and attention in children and adolescents who have been diagnosed with brain tumors. First, we will use a longitudinal design in which, in collaboration with Dr. Wellons (pediatric neurosurgeon) and Dr. Friedman (pediatric hematology/oncology), we will recruit patients at the time of their diagnosis and conduct cognitive testing pre-surgery and at approximately 10 weeks post diagnosis (randomization), 5-7 weeks post Cogmed start (post-intervention), 10-20 weeks post Cogmed start (follow-up), and 1 year post diagnosis (long term follow-up). Second, we will embed a test of the efficacy of Cogmed in this longitudinal design by randomizing patients at 10-weeks post-diagnosis. Half will undergo Cogmed computerized adaptive cognitive training (treatment condition) for 5 weeks and half will be assigned to the non adaptive Cogmed computerized cognitive training (control condition). We will use near infrared spectroscopy, a noninvasive functional imaging method that uses infrared light to detect changes in cortical hemoglobin levels at randomization, post-intervention, follow-up, and long term follow-up. We expect that Cogmed, which will be administered at home or in the hospital, will be feasible and acceptable for the majority (85% or more) of patients. Further, we hypothesize that adaptive Cogmed training will help improve working memory and attention skills and increase frontal cortical activity in the brain tumor patients who receive the remediation program compared to those who receive the non-adaptive control version of the program. Using growth curve analyses, we expect that patients who receive the intervention will show a deflection in the negative trajectory of cognitive functions over time. Findings from this pilot study will be used to develop an application for a multi-site randomized clinical trial to test this intervention in a large sample of pediatric brain tumor patients.
- Conditions
- Brain Tumor
- Being tested
- Cognitive training
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Non-adaptive cognitive training | Placebo comparator | Non-adaptive cognitive training Receives: Behavioral: Cognitive training |
| Adaptive cognitive triaining | Experimental | Adaptive cognitive training Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox-Cognition Battery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study start1 Feb 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bruce Compas, Vanderbilt University
- Investigators
- Bruce E Compas, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129712
- Sponsor's protocol ID
- 121214
- Other IDs
- 1R21CA175840-01
- Acronym
- CRPBT
- Status last verified
- Sep 2018
- First submitted
- 30 Apr 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity-Based Cognitive Remediation for Pediatric Brain Tumor Survivors
- ClinicalTrials.gov ID
- NCT02129712
- Acronym / sponsor ID
- CRPBT / 121214
- Conditions
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will leverage novel pilot research conducted by the investigators to take important first steps in addressing neurocognitive late effects by intervening early, during treatment, with a promising computerized cognitive remediation program to prevent the downward trajectory of neurocognitive function experienced by pediatric brain tumor survivors. Specifically, we propose to test the feasibility, acceptability, and initial proof of concept of a neuroplasticity-based adaptive cognitive training program (Cogmed) to train working memory (WM) and attention in newly diagnosed youth with a brain tumor. Further, we will test the feasibility of using this intervention in a true prospective design beginning pre-surgery to examine the effects of this intervention in deflecting the downward trajectory of cognitive function in children with brain tumors during treatment. We will also use functional neuroimaging (near infrared spectroscopy - "NIRS") to examine the effects of this program on brain activation in frontal regions that are affected by treatment. Findings from this pilot study will inform the development of a large multi-site randomized efficacy trial to test an individualized cognitive training program.
Aim 1. To test the feasibility and acceptability of enrolling youth (7 to 16 years-old) with newly diagnosed brain tumors at time of diagnosis, following patients for 10 weeks, delivering the Cogmed computer-based training program in a randomized trial at 10-weeks post-diagnosis, and following patients to 1 year post-diagnosis.
Aim 2. To test the initial acceptability and efficacy of the Cogmed training program on cognitive function in newly diagnosed pediatric brain tumor patients.
Detailed description
Over 4,000 children are diagnosed with brain tumors in the U.S. each year and advances in treatment have led to significant increases in survival rates for these patients. However, as a result of the disease and treatment with surgery, radiation, and chemotherapy, pediatric brain tumor patients show deficits in frontal lobe functions including several aspects of executive function, showing significant declines over time. Remediation of these deficits is a critical target for research. Major changes in brain maturation and connectivity occur during childhood and adolescence, making this a potentially critical window of opportunity for neuroplasticity-based cognitive interventions to support the neural changes that integrate multiple key regions. Computerized cognitive training programs have been used successfully with patients with schizophrenia, individuals with ADHD, and prodromal adolescents at risk for psychosis. However, these programs have been limited in their application to pediatric brain tumor survivors and untested in brain tumor patients who are undergoing treatment. We aim to blend longitudinal and intervention research designs used successfully in previous studies to test the feasibility, acceptability, and initial efficacy of a neuroplasticiy-based cognitive training program, Cogmed, to enhance working memory and attention in children and adolescents who have been diagnosed with brain tumors. First, we will use a longitudinal design in which, in collaboration with Dr. Wellons (pediatric neurosurgeon) and Dr. Friedman (pediatric hematology/oncology), we will recruit patients at the time of their diagnosis and conduct cognitive testing pre-surgery and at approximately 10 weeks post diagnosis (randomization), 5-7 weeks post Cogmed start (post-intervention), 10-20 weeks post Cogmed start (follow-up), and 1 year post diagnosis (long term follow-up). Second, we will embed a test of the efficacy of Cogmed in this longitudinal design by randomizing patients at 10-weeks post-diagnosis. Half will undergo Cogmed computerized adaptive cognitive training (treatment condition) for 5 weeks and half will be assigned to the non adaptive Cogmed computerized cognitive training (control condition). We will use near infrared spectroscopy, a noninvasive functional imaging method that uses infrared light to detect changes in cortical hemoglobin levels at randomization, post-intervention, follow-up, and long term follow-up. We expect that Cogmed, which will be administered at home or in the hospital, will be feasible and acceptable for the majority (85% or more) of patients. Further, we hypothesize that adaptive Cogmed training will help improve working memory and attention skills and increase frontal cortical activity in the brain tumor patients who receive the remediation program compared to those who receive the non-adaptive control version of the program. Using growth curve analyses, we expect that patients who receive the intervention will show a deflection in the negative trajectory of cognitive functions over time. Findings from this pilot study will be used to develop an application for a multi-site randomized clinical trial to test this intervention in a large sample of pediatric brain tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-adaptive cognitive training | Placebo comparator | Behavioral: Cognitive trainingNon-adaptive cognitive training |
| Adaptive cognitive triaining | Experimental | Behavioral: Cognitive trainingAdaptive cognitive training |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newly diagnosed brain tumor patients who are between the ages of 7 years and 16 years, 11 months old and their parents
- Patients and their parents must be fluent English speakers
Key exclusion criteria (3 listed)
- Patient's brain tumor diagnosis cannot be a recurrence of a previous cancer
- No previous history of another form of cancer
- Patients who are deemed legally blind will be excluded from participating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive training | Behavioural | Adaptive cognitive triaining, Non-adaptive cognitive training |
Primary outcome
NIH Toolbox-Cognition Battery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce E Compas, PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Brain Tumor, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Toolbox-Cognition Battery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.